Nifedipine Versus Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa

Placenta Previa Clinical Trial

Official title:

Oral Nifedipine Versus Intravenous Magnesium Sulfate for Prevention of Preterm Labor in Symptomatic Placenta Previa: Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542552
• Other study ID #: ONIMS
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Antepartum hemorrhage is defined as bleeding from or within the female genital tract, occurring from 28+0 weeks of pregnancy and till delivery of the fetus. it occurs in 3-5% of pregnancies and is an important cause of perinatal and maternal morbidity and mortality worldwide

Description:

There are many tocolytic agents may have a role in conservative management of placenta previa such as magnesium sulfate, calcium channel blockers and β-sympathormimetics. In 2004 Sharma suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Estimated gestational age : between 28 weeks and 37 week's gestation

• Confirmed Placenta previa; either major or minor degrees.

• Placenta previa with preterm uterine contractions

Exclusion Criteria:

• Severe attack of bleeding requiring an immediate intervention.

• Fetal heart rates instability or non-reassuring tracing

• Intrauterine fetal death or major fetal anomalies.

• If associated with abruptio placentae

• Patients with known bleeding disorders or on anticoagulant therapy

• Patients with severe medical disorders as myasthenia gravis documented magnesium toxicity.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Placenta Previa

Intervention

Drug:
• Magnesium Sulfate
Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
• Nifedipine
received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of prolongation of gestation	measured from the time of enrollment to the time of delivery	1 month